# K180336: syngo.MR Applications

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 19, 2018 after 71 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K971684 (1997). 190 ancestors in all.
21 later devices descend from it; 4 cite it directly.
5 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology, Siemens Medical Solutions USA, Inc. (2017) Summary page 12.
- K151353: syngo.MR Neurology, syngo.MR Oncology, Siemens Medical Solutions USA, Inc. (2015) Summary page 9.
- K120315: Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro Extension, Siemens Medical Solutions USA, Inc. (2012) Summary page 12.
- K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular, Siemens Medical Solutions USA, Inc. (2013) Summary page 12.
- K133401: Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General, Siemens Medical Solutions USA, Inc. (2014) Summary page 12.

## Most influential descendants
- K182904: syngo.MR Applications (2019), 14 descendants of its own
- K193290: AI-Rad Companion Brain MR (2020), 11 descendants of its own
- K220497: CoLumbo (2022), 6 descendants of its own
- K213706: AI-Rad Companion Brain MR (2022), 3 descendants of its own
- K241211: CoLumbo (2024), 2 descendants of its own

Source page: https://510kreport.com/device/K180336
Methodology: https://510kreport.com/methodology